Facilitating COVID-19 Test for Korean Americans Through Korean Schools in Northern California

NCT05435482 | Completed Results

• 2 other identifiers: R0102U24MD016258
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

In collaboration with Korean Schools of Northern California, the investigators will test if a community-based intervention delivered by lay health educators (LHEs) increases testing uptake among Korean Americans. A pilot cluster randomized controlled trial (RCT) with 300 participants from about 12 Korean Schools will be conducted to evaluate the efficacy of the LHE-led intervention in promoting COVID-19 testing. Participating schools will recruit Korean Schoolteachers as LHEs. According to the group assignment of schools where participants are recruited, the LHE group participants will receive 1) LHE outreach/support, 2) COVID-19 at-home antigen test kits, and 3) the instruction to use the kit while the control group participants will receive test kits and the instruction. Participants will complete an online survey at baseline, weeks 4, and 8. The primary outcome is the COVID-19 testing receipt. The secondary outcomes are intention to get tested, perceived accuracy, benefits and risks of testing, perceived barriers to testing, understanding of negative or positive results, and family members' testing receipt.

Conditions

Educational Activities

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Who Has Been Tested for COVID-19 During the Study Period

  Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program

  Week 4

• Proportion of Participants Who Has Been Tested for COVID-19 During the Study

  Participants are asked to self-report whether they have been tested for COVID-19 since participation of the intervention program

  Week 8

Secondary Outcomes (2)

• Intention to Get Tested for COVID-19

  Week 4

• Intention to Get Tested for COVID-19

  Week 8

Study Arms (2)

LHE-led

EXPERIMENTAL

Participants will receive 1) LHE outreach/support (2 small group educational sessions via Zoom and 2 individual follow-up calls), 2) COVID-19 at-home antigen test kits, and 3) a written and a video guide to using a test kit

Behavioral: Education; Other: COVID-19 testing kits; Other: Instruction

Instruction only

ACTIVE COMPARATOR

Participants will receive 1) COVID-19 at-home antigen test kits and 2) a written and a video guide to using a test kit

Other: COVID-19 testing kits; Other: Instruction

Interventions

Education BEHAVIORAL

Participants will receive two small group meetings and two follow-up calls

LHE-led

COVID-19 testing kits OTHER

Participants will receive two COVID-19 at-home antigen test kits.

Instruction only; LHE-led

Instruction OTHER

Participants will receive a written guide and a video clip guide to the test kit.

Instruction only; LHE-led

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 and older;
• self-identify as Korean or Korean American;
• fluent in spoken and written Korean; and
• live in communities where participating schools are located.
• age 18 and older;
• self-identify as Korean or Korean American;
• read and speak English or Korean;
• live in communities where participating schools are located; and
• have access to a phone to receive follow-up calls from LHEs.

You may not qualify if:

• Participating as community advisory group member for the study

Sponsors & Collaborators

• University of California, San Francisco: lead
• Duke Clinical Research Institute: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Ji Won Choi
• Organization: University of California, San Francisco

jiwon.choi@ucsf.edu

415.340.1434

Study Officials

• JiWon Choi, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 28, 2022
• Study Start: October 3, 2022
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 11, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Approximately 9 months after data completion
• Access Criteria: De-identified data will be shared upon request with a data use agreement

Locations

US (1)